A study to see the effects of Mupirocin 2% cream of Glasshouse Pharmaceuticals Limited in patients with Infected Skin Lesio
- Conditions
- Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2019/12/022540
- Lead Sponsor
- Glasshouse Pharmaceuticals Limited Canada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy male or non-pregnant female aged >= 18 months till 70 years with a secondarily infected traumatic skin lesion(s) such as a laceration, sutured wound or abrasion
2. The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed 100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of the abrasion
3. Positive baseline culture for Staphylococcus aureus and/or Staphylococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion
4. Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion
5. Subjects willing to give written informed consent or assent as appropriate
6. Not pregnant / not planning to be pregnant / not a lactating female. Females of childbearing potential and male subjects will be included in the study if they are willing to use an appropriate method of contraception
7. Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline
1. Pregnant, breastfeeding, or planning pregnancy
2. Any dermatological disorder that may interfere with evaluation of the subjectâ??s secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area
3. Bacterial skin infection which, due to depth of severity, could not be appropriately treated by a topical antibiotic (e.g., severe cellulitis, abscess, ulcers, furunculosis)
4. Secondarily infected animal/human or insect bite or puncture wound
5. Systemic sign and symptoms of infection (i.e., fever defined as an oral temperature greater than 101â?¦F or 38.3â?¦C)
6. Require surgical intervention for treatment of the infection prior to enrolment in the study
7. Subjects who have applied any topical corticosteroid, topical antibiotic, or antifungal agent for at least 48 hours (2 days) prior to baseline
8. Subjects who have been treated with a systemic antibiotic or systemic corticosteroid within 7 days prior to baseline
9. Subjects with primary or secondary immunodeficiency
10. Subjects with known history of diabetes
11. Presence of any other medical condition that might adversely impact the safety of the study participants or confound the study results
12. History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients
13. Subjects who are alcohol or drug dependent i.e. substance of abuse
14. Treatment with an investigational drug or device within 30 days prior to study entry
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method